Boston Scientific Corporation: Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Hazard

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

Details from the source

Reason for recall: The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa. Distribution: US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA. Quantity: 156 units Lot/code info: Instructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;

UPC codes

08714729790280, 08714729790266

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.